NCT00185094

Brief Summary

To examine the effect of three different blood pressure medications on the insulin sensitivity in overweight patients with high blood pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

December 23, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

December 22, 2005

Conditions

HypertensionInsulin ResistanceMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • To compare the treatment effect of olmesartan medoxomil versus that of atenolol on insulin sensitivity

Secondary Outcomes (2)

  • -To compare the treatment effect of losartan potassium versus atenolol on insulin sensitivity

  • -To compare the treatment effect of olmesartan medoxomil versus losartan potassium on insulin sensitivity

Interventions

Olmesartan medoxomilDRUG
Losartan potassiumDRUG
AtenololDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of 18 and 75 years (inclusive)
  • Willingness to undergo insulin clamp procedure twice
  • Overweight or obese (BMI=25-39 kg/m2)
  • Subject must meet one of the following two blood pressure criteria at week-2 and at week-1: Systolic blood pressure 140-179 mmHg and diastolic blood pressure 85-99 mmHg OR Systolic blood pressure \< 140 mmHg and diastolic blood pressure 90-99 mmHg
  • If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

You may not qualify if:

  • Systolic blood pressure \> 179 mmHg
  • Diastolic blood pressure \> 99 mmHg or \< 85 mmHg
  • Diagnosis of diabetes mellitus
  • History of myocardial infraction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, unstable angina pectoris or an episode of heart failure requiring hospitalization
  • Previous history of a cerebrovascular accident or a transient ischemic attack
  • History of allergic response to atenolol, losartan potassium, olmesartan medoxomil or any of their components
  • Any serious disorder, including pulmonary, hepatic, renal, gastrointestinal (including clinically significant malabsorption), uncontrolled endocrine/metabolic, hematologic/oncologic (within the last 5 years), neurologic, and psychiatric diseases, that would interfere with the conduct of the study or interpretation of the data
  • Laboratory abnormalities that could compromise subject safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

HypertensionInsulin ResistanceMetabolic Syndrome

Interventions

Olmesartan MedoxomilLosartanAtenolol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

February 1, 2004

Study Completion

July 1, 2005

Last Updated

December 23, 2005

Record last verified: 2005-09

Locations

US(10)